National Snapshot Study Adhesive Small Bowel Obstruction (ASBO)

NCT03786159 | Unknown

• 1 other identifier: SnapshotASBO
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Over 63-90% of patients develop peritoneal adhesions after abdominal or pelvic surgery. Which makes it the most common complication after abdominal or pelvic surgery. Adhesions comprise a lifelong risk of adhesion related complications.The most frequent emergency complication of adhesion is an episode of adhesive small bowel obstruction (ASBO). Over 1 in 5 patients experiences at least 1 episode of ASBO in the 10 years following initial abdominal surgery. Despite the high incidence of ASBO, diagnosis and treatment of an episode of ASBO varies greatly between hospitals and even between doctors. Until now, optimal treatment patterns are unknown. The aim of this study is mapping of care for patients with a suspected episode of ASBO. With the collected data new hypothesis will be generated for the ideal diagnostic and therapeutic workflow for patients with a suspicion of an episode of ASBO.

Conditions

Surgery-Induced Tissue Adhesion; Surgical Adhesions; Adhesion, Tissue

Outcome Measures

Primary Outcomes (6)

• CT treatment ASBO

  In how many patients does CT-scan impact initial management of ASBO (i.e. different cause of SBO found, or conservative trial vs. direct surgery)?

  February 2021

• Diagnostics ASBO

  How many patients in the Netherlands presenting with adhesive small bowel obstruction have a CT-scan in their diagnostic work-up?

  February 2021

• Timeframe conservative trial ASBO

  How long do Dutch surgeons continue a conservative trial in patients with persistent obstruction who are not clinically deteriorating? Outcome measures will be based on data from the online Case Report Form (CRF).

  February 2021

• Conservative trial > 72 hours ASBO

  Does continuing a conservative trial for more than 72 hours adverse impact final outcomes? Complications as measured by Clavien-Dindo will be registered and compared between groups.

  February 2021

• Laparoscopic surgery for ASBO

  How many patients that are surgically treated for ASBO in the Netherlands have laparoscopic surgery?

  February 2021

• Outcome laparoscopic surgery for ASBO

  What are the outcomes of laparoscopic surgery for ASBO? Days of in hospital stay, postoperative complications (Clavien-Dindo) and 90-day readmissions rates will be compared between patients who underwent open or laparoscopic surgery for ASBO.

  February 2021

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with a suspicion of ASBO, older than 17 years, can be included in the present snapshot study. Patients with an episode of small bowel obstruction that is certainly not caused by adhesions fall outside of the scope of this study (eg. tumor as cause of SBO).

You may qualify if:

• Suspicion ASBO
• Age 18 years or older

You may not qualify if:

• Clear other cause of small bowel obstruction (e.g. tumor, hernia)

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6500HB, Netherlands

RECRUITING

Related Publications (7)

• Ellis H, Moran BJ, Thompson JN, Parker MC, Wilson MS, Menzies D, McGuire A, Lower AM, Hawthorn RJ, O'Brien F, Buchan S, Crowe AM. Adhesion-related hospital readmissions after abdominal and pelvic surgery: a retrospective cohort study. Lancet. 1999 May 1;353(9163):1476-80. doi: 10.1016/S0140-6736(98)09337-4.

  PMID: 10232313 BACKGROUND

• Parker MC, Ellis H, Moran BJ, Thompson JN, Wilson MS, Menzies D, McGuire A, Lower AM, Hawthorn RJ, O'Briena F, Buchan S, Crowe AM. Postoperative adhesions: ten-year follow-up of 12,584 patients undergoing lower abdominal surgery. Dis Colon Rectum. 2001 Jun;44(6):822-29; discussion 829-30. doi: 10.1007/BF02234701.

  PMID: 11391142 BACKGROUND

• Luijendijk RW, de Lange DC, Wauters CC, Hop WC, Duron JJ, Pailler JL, Camprodon BR, Holmdahl L, van Geldorp HJ, Jeekel J. Foreign material in postoperative adhesions. Ann Surg. 1996 Mar;223(3):242-8. doi: 10.1097/00000658-199603000-00003.

  PMID: 8604903 BACKGROUND

• Menzies D, Ellis H. Intestinal obstruction from adhesions--how big is the problem? Ann R Coll Surg Engl. 1990 Jan;72(1):60-3.

  PMID: 2301905 BACKGROUND

• Diamond MP, Freeman ML. Clinical implications of postsurgical adhesions. Hum Reprod Update. 2001 Nov-Dec;7(6):567-76. doi: 10.1093/humupd/7.6.567.

  PMID: 11727865 BACKGROUND

• Hershlag A, Diamond MP, DeCherney AH. Adhesiolysis. Clin Obstet Gynecol. 1991 Jun;34(2):395-402. doi: 10.1097/00003081-199106000-00023.

  PMID: 1831077 BACKGROUND

• Beck DE, Opelka FG, Bailey HR, Rauh SM, Pashos CL. Incidence of small-bowel obstruction and adhesiolysis after open colorectal and general surgery. Dis Colon Rectum. 1999 Feb;42(2):241-8. doi: 10.1007/BF02237135. Erratum In: Dis Colon Rectum 1999 May;42(5):578.

  PMID: 10211502 BACKGROUND

MeSH Terms

Conditions

Tissue Adhesions

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard PG ten Broek, PhD, MD

  Radboudumc, departement of surgery

  STUDY DIRECTOR

Central Study Contacts

Pepijn Krielen, MD

CONTACT

0243613808; pepijn.krielen@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 24, 2018
• Study Start: April 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2021
• Last Updated: October 28, 2019

Record last verified: 2018-11

Locations

NL (1)